Validation Engineer 3

Merck•Jaffrey, NH

4d•Onsite

About The Position

The Validation Engineer III is an advanced level validation engineering position responsible for executing complex validations and qualifications of equipment, materials, processes and tests used in the production of high purity filters, prioritizing a focus on quality and safety. Responsible for establishing and maintaining qualification techniques. This position may lead lower-level engineers to ensure their projects meet validation standards. This role requires close collaboration with cross functional teams to assess risk, disposition product, resolve complex problems, and ensure projects and programs meet their expected objectives.

Requirements

Bachelor’s Degree in STEM (engineering, sciences, or computer science, etc.), technical management, business management.
5+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry leading the validation of automated and manual assembly processes with working knowledge of ISO, cGMPs and Good Engineering Practices.

Nice To Haves

Master of Science Degree in STEM (engineering, sciences, or computer science, etc.), technical management, or business management.
Read and understand complex mechanical and electrical drawings and P&ID’s.
Lean/Six Sigma experience, with a green or black belt certification.
Experience with HMI/PLC and preferred code knowledge.
Strong communication skills.
Manage and lead multiple projects and participate on cross-functional project teams.
Must be self-driven, able to work independently, and in teams with urgency.
Proven ability to analyze complex data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
Experience with Microsoft products, Minitab, and CAD software packages.
Understand safe work practices and experience in lockout, tag out, electrical safety, etc.

Responsibilities

Expert with Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and Performance qualifications (temperature mapping and process qualification).
Drive validation requirements needed for advanced manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
Coordinate the scheduling of validation execution by collaborating with Manufacturing, Planning and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
Prepare, maintain, and review Validation documentation such as CQV documentation for DQ, FAT, IQ, OQ, PQ, and process qualification.
Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment and GMP production.
Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
Represent the Validation department during internal and external audits.
Brings solution recommendations to management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
Provide guidance and mentorship to team members and contractors regarding cycle development and validation of complex manufacturing equipment and raw material changes.
Proficient at developing complex project plans to drive process improvements or changes, and capable of leading a cross functional team to meet deadlines.
Able to anticipate challenges and roadblocks, and experiments with alternative and innovative solutions to avoid just refining existing solutions.
Highly skilled at building consensus with a cross functional team at all levels and converting vision into clear goals and milestones.
Facilitates effective teamwork by actively managing team dynamics.
Anticipates challenges by utilizing knowledge / history to prevent issues from occurring.
Helps develop other experts by giving concrete advice, coaching, and mentoring on how to succeed in a business setting.
Leads Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions, implementing robust solutions to address root cause and prevent events from reoccurring.
Expert technical writing skills and strong understanding of Current Good Manufacturing Practices (cGMP).
Proficient at leading complex equipment and process validations activities, including protocol and report writing, review and execution.
Leads strategic or complex change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards.
Anticipate roadblocks and challenges and navigate the team through problems to meet deadlines.